NCT04028817

Brief Summary

This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

July 19, 2019

Last Update Submit

June 11, 2020

Conditions

Parkinson Disease

Keywords

parkinson's diseasePhotobiomodulationInflammationOxidative stress

Outcome Measures

Primary Outcomes (1)

  • 10-meter walk test

    This evaluation will be carried out from the application of the tem meter walk test. The test will be performed in a straight hall, with a line 14 meters long. The first 2 meters marked, will be provided so that the patient reaches the usual walking speed, and the last 2 meters will be provided for the patient to decelerate and stop. At the start of the test, patients will receive walking guidance at a comfortable pace.

    1 day

Study Arms (2)

group treatment

EXPERIMENTAL

This group will receive laser treatment combined with low intensity exercises

Device: photobiomodulation

group control

PLACEBO COMPARATOR

This group will receive placebo laser treatment combined with low intensity exercises

Device: placebo photobiomodulation

Interventions

photobiomodulationDEVICE

the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied sublingual laser in a single point, with wavelength of 808 nm, diameter of 0.4 cm, with irradiance of 0.8 w / cm2, for 360 s, the laser applied will be of continuous wave with energy of 36J.

Also known as: low level laser therapy
group treatment
placebo photobiomodulationDEVICE

the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied a placebo sublingual laser for 360 s.

group control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons' Disease Society Brain Bank Clinical Diagnostic Criteria
  • In the stages I to III of the disease according to Hoehn \& Yahr's Parkinson's disease staging scale - modified;
  • Individuals of both sexes,
  • with more than 50 years
  • who sign the informed consent form

You may not qualify if:

  • patients who present some adverse event during the development of the study,
  • Who have another associated neurodegenerative disease,
  • Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections, neoplasias, respiratory disorders, hypophysis and hypothalamus problems.
  • Who fail to understand or perform procedures correctly because of physical and mental limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daysi da Cruz Tobelem

São Paulo, 04119010, Brazil

Location

MeSH Terms

Conditions

Parkinson DiseaseInflammation

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 23, 2019

Study Start

September 10, 2020

Primary Completion

August 10, 2021

Study Completion

December 30, 2021

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

BR(1)